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临床试验/NCT04497194
NCT04497194已完成不适用

Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)

Azienda Ospedaliera Universitaria Integrata Verona1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
430
试验地点
1
主要终点
Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona

研究概览

简要总结

The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.

详细描述

Anamnestic data are collected at the enrollment, while all the other clinical and epidemiological information are retrieved retrospectively from patients' medical records and electronic health records.

Serological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs) are collected within 48 hours after admission and during the hospital stay, according with routine internal procedures.The biological samples are stored at the University Laboratory for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM).

A dedicated database has been created and implemented to collect all the above mentioned information.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing swab;
  • All ages;
  • All genders;
  • Informed consent obtained.

排除标准

  • Failure to obtain the informed consent.

结局指标

主要结局

Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

pH

Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Blood pressure (mmHg)

Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Pulse rate (beats per minute)

Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Peripheral oxygen saturation (%)

Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Body temperature (°C)

Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Lymphocytes (cell/mm3)

L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

LDH (mU/ml)

Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

CK (U/L)

Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.

C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

CRP (m/gL)

Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission

Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Pulse rate (beats per minute)

Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Platelets (cell/mm3)

D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

D-dimer (μg/L)

ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

ferritin (mcg/L)

Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Creatinine (mg/dl)

Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

PCT (ng/mL

Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

Neutrophils (cell/mm3)

AST (U/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

AST (U/L)

Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

HCO3 (mmol/l)

White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

White Blood Count (WBC, cell/mm3)

fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

fibrinogen (g/L)

ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

ALT (U/L)

Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

pO2 (mmHg)

Virological factors associated with the pathogenesis of COVID-19

时间窗: through study completion, an average of 3 months

Nasal and rectal swabs, fecal samples and blood samples

Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

pCO2 (mmHg)

Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona

时间窗: through study completion, an average of 3 months

SpO2 (%)

Host-related factors associated with the pathogenesis of COVID-19

时间窗: through study completion, an average of 3 months

IL-6 (pg/mL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evelina Tacconelli

Professor

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (1)

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Registry of COVID-19 Patients at AOUI Verona | 临床试验